(AUSTIN, Texas, May 28, 2013) Interest in the North American herb black cohosh (Actaea racemosa; synonym, Cimicifuga racemosa) has increased immensely during the past 60 years, and with it, incidences of accidental and economically motivated adulteration with lower-cost Chinese species whose scientific names may appear similar. “Exploring the Peripatetic Maze of Black Cohosh Adulteration,” a new report by noted author and photographer Steven Foster, has been published in the latest issue of HerbalGram, the peer-reviewed journal of the nonprofit American Botanical Council.¹

The article is the latest in a series from the ABC-AHP-NCNPR Botanical Adulterants Program. The report thoroughly examines the many facets of the real concern of black cohosh adulteration, including confusing nomenclature, market economics, history of alleged liver toxicity possibly associated with the adulterants, and analytical tests available to ensure correct identity of black cohosh.

Black cohosh frequently is used to treat symptoms of menopause, in addition to other conditions related to female reproductive health that have been supported to various extents by published clinical trials. In the United States, it is unlawful for any herb other than Actaea racemosa to be sold as black cohosh. The article states, “Any designation of a botanical material or finished product in the US by the common name of ‘black cohosh’ on product labels (and presumably in the supply chain) is required to be Actaea racemosa and no other species.” To apply the name “black cohosh” to any other species violates federal law, resulting in misbranding of the finished product offered to consumers. Such a product is considered adulterated under the law.

“The sheer volume of offerings, prices ranges, varied specifications, and differing species listed as ‘black cohosh extract’ from Chinese sources requires that the daunted buyer [in the herb industry] attempting to source black cohosh work closely with a qualified analytical lab to authenticate black cohosh extracts before securing any supply source,” the report says.

In 2002, reports of alleged liver toxicity related to black cohosh began to appear. According to the report, adulteration of black cohosh with other plant species is likely to blame, at least in part, for those incidents, as later analyses found the association of true black cohosh with liver disease to have a weak or uncertain causal link or no causal link at all.

The report states that, “Mislabeling or confusion may be due to simple language and translation variations, or, in some cases, the actual intent to sell a lower-cost material that is not an acceptable substitute for authentic North American black cohosh. However, these are possibly moot points as all of the identification and authentication scientific tools necessary to distinguish authentic black cohosh from any other plant materials of any origin are readily available.”

A number of laboratory authentication methods are outlined by Foster, including various types of chemical testing and the more recently developed DNA fingerprinting. The report also cites the American Herbal Pharmacopoeia’s (AHP) 2002 black cohosh rhizome monograph, a comprehensive resource on known adulterants that includes botanical, microscopic, and chemical analyses of black cohosh.²

AHP executive director Roy Upton, editor of the AHP Black Cohosh Rhizome monograph stated, "This issue of black cohosh adulteration is not new. The black cohosh monographs of AHP and the U.S. Pharmacopeia, as well as a number of analytical papers published the past few years, provide the primary tools needed by industry to develop appropriate specifications and implement the necessary quality control processes to keep adulterated materials from entering into the consumer product market. The key is to get this information disseminated to management, quality control, analytical, and purchasing personnel in the herb and dietary supplement industry. This is the goal of the Botanical Adulterants Program."

“Solving the problem of economic adulteration of black cohosh products is within reach,” according to the report. “Many in the herb industry are acutely aware of the need for fulfillment of current Good Manufacturing Practices (cGMPs) as FDA increases cGMP inspections, compliance, and the issuance of letters [by the US Food and Drug Administration]. Clearly, the crux of the problem of black cohosh adulteration lies squarely on the doorstep of intentional economic adulteration of black cohosh with less expensive materials from China.”

“From this point on, there is literally no excuse for any manufacturer or reseller of herbal dietary supplements to purchase raw material or extracts labeled as being ‘black cohosh’ without conducting appropriate analytical procedures to verify and authenticate the herb’s proper identity,” said Mark Blumenthal, founder and executive director of ABC, and editor-in-chief of HerbalGram. “In our view, anyone offering for sale the Chinese species of Actaea (primarily A. cimicifuga, A. dahurica, A. heracleifolia, and A. simplex) as ‘black cohosh’ is most likely knowingly selling adulterated material. This is likely fraud, and such sellers of these adulterants should be prosecuted to the fullest extent of the law.”

“The first priority in quality control of botanicals is ensuring proper identity,” Blumenthal continued. “There are many ethical and responsible manufacturers of black cohosh dietary supplements that produce authentic products. It is highly unfortunate that this traditional North American herb has been adulterated by suppliers of inauthentic raw materials.”

Blumenthal added that, “The purpose and intention of the ABC-AHP-NCNPR Botanical Adulterants Program is to educate the botanical dietary supplement industry and its related stakeholders regarding the presence of confirmed botanical adulterants within the global supply chain. This helps manufacturers ensure that they detect adulterated material so that their products contain properly identified, authenticated herbal raw materials and extracts. Ultimately, this Program’s vision is that consumers will have access to more reliable dietary supplements and related herbal products.”

“It is past time for all members of the herb and dietary supplement industry in the United States, and the botanical products industry around the world, to institute and adhere to appropriate quality control measures related to properly identifying and authenticating black cohosh products, as well as all herbal products,” wrote Blumenthal in his Dear Reader column in the same issue of HerbalGram.³

This comprehensive black cohosh adulteration report contains several tables and 91 references, is the fifth article in the ABC-AHP-NCNPR Botanical Adulterants Program series, and is the fourth that has been written by Foster. Foster’s previous articles in the series include the history of adulteration of herbs, spices, and botanical drugs during the past 2,000 years; the adulteration of skullcap (Scutellaria lateriflora) with germander (Teucrium spp.); and the adulteration of commercial bilberry (Vaccinium myrtillus) extracts. The series also includes a review article by John H. Cardellina II, PhD, of analytical studies on so-called “grapefruit seed extract,” which has been shown to be adulterated with synthetic industrial disinfectants.

References

1. Foster S.  Exploring the peripatetic maze of black cohosh adulteration. HerbalGram. 2013;98:32-51. Available at: http://cms.herbalgram.org/herbalgram/issue98/hg98feat-blackcohosh.html.

2. Upton R (ed). Black Cohosh Rhizome, Actaea racemosa L., syn. Cimicifuga racemosa (L.) Nutt.: Standards of Analysis, Quality Control, and Therapeutics. Santa Cruz, CA: American Herbal Pharmacopoeia; 2002.

3. Blumenthal M. Adulteration of black cohosh [Dear Reader column]. HerbalGram. 2013;98:6. Available at: http://cms.herbalgram.org/herbalgram/issue98/hg98dearreader.html.

About the ABC-AHP-NCNPR Botanical Adulterants Program


The ABC-AHP-NCNPR Botanical Adulterants Program is a consortium of independent nonprofit organizations whose mission relates to education, scientific research, and quality of botanical dietary ingredients and related plant-derived materials. The consortium is headed by three nonprofit groups dealing with research and education on medical herbs and other beneficial plants: the American Botanical Council, the American Herbal Pharmacopoeia, and the National Center for Natural Products Research at the University of Mississippi. The program is underwritten or endorsed by more than 100 natural product industry companies, independent analytical laboratories, contract research organizations, nonprofit and professional organizations, trade associations, accredited institutions of education in natural medicine, law firms, and media companies — which are involved in the production, supply, manufacture, distribution, marketing, analysis, research, and/or education of herbal dietary ingredients and supplements, in the United States and internationally. Companies, organizations, foundations, and/or individuals interested in supporting this program are invited to contact Ms. Denise Meikel, ABC development director, at (512) 926-4900, ext. 120, or by email.

Underwriters and Supporters of the ABC-AHP-NCNPR Botanical Adulterants Program (as of May 23, 2013)*